UMIN-CTR Clinical Trial

Public title

A evaluation study of the effect of test food on human sleep.
-Open Study-

Acronym

A evaluation study of the effect of test food on human sleep.

Scientific Title

A evaluation study of the effect of test food on human sleep.
-Open Study-

Scientific Title:Acronym

A evaluation study of the effect of test food on human sleep.

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effect of test food on human sleep.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

EEG during sleep (Sleep scope)

Key secondary outcomes

The Japanese version of the Pittsburgh Sleep Quality Index
OSA sleep inventory MA version
Visual Analogue Scale

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Take test food once a day, 2 capsules, for 4 weeks.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

30

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Males and females from 30 to 59 years of age.
2. Subjects with a PSQI-J global score of 6 or higher at the time of screening test.
3. Subjects who can make self-judgment and are voluntarily giving written informed consent.

Key exclusion criteria

1. Subjects who are currently under treatment for sleep, stress and fatigue, and who are using medicines and health foods related to sleep, stress and fatigue.
2. Subjects who consistently drink more than the appropriate amount of alcohol (about 20 g of pure alcohol per day).
3. Subjects who aren't abele to stop eating foods and drinks high in caffeine from 15:00 to bedtime during this research period.
4. Subjects who are midnight-shift worker or shift worker.
5. Subjects who are suffering from, undergoing treatment for, or with a history of serious diseases such as diabetes, kidney / liver disease, heart disease or thyroid disease, adrenal disease, and other metabolic diseases.
6. Subjects who have chronic diseases and take medication on a daily basis.
7. Subjects who have a history of pollinosis or a current medical history, and who plan to use or take the drug during this research period.
8. Subjects who have been diagnosed with sleep apnea syndrome.
9. Subjects who have sensitive skin and may cause skin inflammation with adhesive plasters or adhesive tape.
10. Subjects with implantable medical devices such as cardiac pacemakers and implantable cardioverter-defibrillators.
11. Subjects who have a history or current condition of drug or alcohol dependence.
12. Subjects who are pregnant or breast-feeding, or have the will of pregnancy during this research period.
13. Women with severe symptoms such as menstrual pain and premenstrual syndrome.
14. Subjects who have food allergy.
15. Subjects who are judged to be inappropriate as research subjects by blood tests in screening tests.
16. Subjects who participate in other clinical trials, who have participated in other tests within one month of obtaining consent, or who are willing to participate.
17. Subjects who plan to travel abroad, including overseas travel, during this research period.
18. Subjects who are judged as unsuitable for the study by the investigator for the other reasons.

Target sample size

20

Name of lead principal investigator

1st name	Yoshitaka
Middle name
Last name	Iwama

Organization

Nihonbashi Cardiology Clinic

Division name

Director

Zip code

103-0001

Address

Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo

TEL

03-5641-4133

Email

yiwama@well-sleep.jp

Name of contact person

1st name	Eiji
Middle name
Last name	Yoshikawa

Organization

KSO Corporation

Division name

Sales department

Zip code

105-0023

Address

1-9-7 Shibaura, Minato-ku, Tokyo

TEL

03-3452-7733

Homepage URL

Email

eigyou27@kso.co.jp

Institute

KSO Corporation

Institute

Department

Personal name

Organization

TEIJIN LIMITED

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Committee of Kobuna Orthopedics Clinic

Address

5-656-17 Joto-machi, Maebashi-shi, Gumma

Tel

027-212-5608

Email

sagawa@mc-connect.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

01

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2021

Year

11

Month

29

Day

Date of IRB

2021

Year

12

Month

02

Day

Anticipated trial start date

2022

Year

01

Month

10

Day

Last follow-up date

2022

Year

03

Month

06

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

01

Month

07

Day

Last modified on

2022

Year

03

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053139